The present project aims to evaluate the effectiveness of a multi-modal, personalized, work-oriented physiotherapy intervention in optimizing work ability (primary outcome) and improving clinical outcomes (secondary outcomes), compared to usual care…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be work ability, assessed by the Work Ability
Index - Single Item Scale at 12 months follow-up.
Secondary outcome
Secondary outcome measures include: work presenteeism and absenteeism, job
satisfaction, and self-efficacy (all work-related outcomes), physical function,
pain, fatigue, anxiety, and depression (all clinical outcomes),
For the economic analysis, utilities, health care/informal care utilization,
and costs will be measured. In addition, in the intervention group only, a
process evaluation will be performed to identify barriers and facilitators of
implementation of the intervention. All outcomes will be measured by
questionnaires, obtained at baseline, 3 and 6 months (secondary time points)
and 12 months follow-up (primary endpoint).
For the process evaluation, individual, semi structured interviews will be
arranged with a selection of participants,
PTs and rheumatologists after 12 months follow-up. Apart from the primary,
secondary and economic outcome measures, personal and disease characteristics
will be recorded. The personal characteristics consists of age, gender, weight,
height, marital status, education level, current work adaptations and history
(<=1 year) of work-oriented treatment or guidance. The disease parameters in
this study include disease duration, current medication and comorbidities.
Background summary
Although work ability is considered a key element of quality of life, work is
generally underexposed in current treatment in
people with Rheumatoid Arthritis (RA) and axial SpondyloArthritis (axSpA). This
is an undesirable situation, as work
ability is reduced compared to the general populations, despite breakthroughs
in the pharmacological
treatment. Physical therapy could potentially play an important role in
optimizing work ability in RA/axSpA, when
focusing on and integrating work-oriented treatment modalities within their
intervention. However, the effects of such an
integrated physiotherapy intervention are not known yet.
Study objective
The present project aims to evaluate the effectiveness of a multi-modal,
personalized, work-oriented physiotherapy intervention in optimizing work
ability (primary outcome) and improving clinical outcomes (secondary outcomes),
compared to usual care, in employees with RA/axSpA after 12 months of
follow-up. Furthermore, this study aims to evaluate the cost-effectiveness of a
multi-modal, personalized, work-oriented physiotherapy intervention in
optimizing economic measures, compared to usual care, in employees with
RA/axSpA after 12 months of follow-up.in employees with RA/axSpA after 12
months of follow-up.
Study design
A randomized, controlled trial (RCT) comparing a work-oriented physiotherapy
intervention (experimental
group) with usual care (control group) (1:1). During the trial of in total 12
months, the experimental and control group will
complete questionnaires on work-related, clinical and economic outcomes at
baseline and follow-up measurements after 3, 6 and 12 months.
Intervention
Intervention and control conditions: The experimental intervention, in addition
to usual care coordinated by the
patient*s rheumatologist, consists of the following modalities:
1. Personalized exercise therapy targeting aerobic capacity, muscle strength,
stiffness and fatigue, and specifically focusing
on work-related activities that are limited due to the disease or relevant for
the type of work;
2. Personalized education and self-management support focusing on RA/axSpA and
adequate self-management strategies
(empowerment), with specific focus on work;
a. Optionally, an additional online self-management training, to further
optimize their self-management and empowerment skills (at work);
3. Personalized work-roadmap to guide the participant in when and how to
receive the necessary support of which
professional within the occupational domain;
a. Optionally, an workplace intervention targeting essential adaptation at work
and/or a workplace dialogue between employee and supervisor.
The control group will receive usual care, coordinated by the patient*s
rheumatologist.
Study burden and risks
Patients randomized to the control arm will be treated as usual by their
rheumatologist, whereas patients from the experimental arm will be additionally
treated by a trained, specialized physical therapist, of which intervention
clinical effects and minimal risks are expected. The burden of the patients
will be minimized to the time necessary for completing the questionnaires and
visiting the physiotherapist . All participants will complete 4 questionnaires
during the study (20-30 minutes each) and the participants in the experimental
arm will visit the physiotherapist for 10-21 times (30 minutes each).
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
A patient should meet all of the following criteria to be eligible:
1. Clinical diagnosis of RA or axSpA, confirmed by a rheumatologist.
2. Having paid employment for >=12 hours/week (including self-employment).
3.Moderate to poor work ability (Work Ability Index-Single Item Scale (WAS)
<=7/10), related to RA/axSpA and/or
self-reported history of sick-leave in the past 6 months related to RA/axSpA.
4. Self-reported limitations in physical functioning.
Exclusion criteria
Patients will be excluded if any of the following criteria are met:
1. Pensionable age within 2 years.
2. Comorbid disease or other (e.g. financial) situation influencing work
ability.
3. Pregnancy.
4. Having a labor dispute.
5. Current sick leave period of more than 6 months.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | NL trial register, ID:NL9343 |
| CCMO | NL75919.058.20 |